跳至主要内容
临床试验/NCT06814886
NCT06814886招募中不适用

Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place: A Randomized Controlled Trial

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Physical activity (subjective)

研究概览

简要总结

Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Wearable devices initiate behavior intervention combined with smartphone applications could offer new opportunities for social connection by a convenient way for nurses to improve physical activity and sleep quality.

Objectives: To evaluate the effects of wearable devices initiate behavioral intervention on body composition, physical activity, sleep quality and stress of nurses in hospital working place.

Method: This is a randomized controlled trial that will recruit 120 nurses and randomly assign them into two groups from a hospital working place. The nurses in the intervention group will receive 12-week wearable devices to initiate behavioral intervention. The nurses in the comparison group will only receive 12-week wearable devices monitoring. Data will be collected at baseline and 12-week and 24-week follow-up. The body composition will be measured by bioelectrical impedance analysis (BIA). The physical activity and sleep quality will be monitored by the Fitbit wearable device and application. The mediator parameter of the stress will be measured by salivary amylase activity (SAA). We will control the internal validity to assure the quality of training, treatment fidelity, identify barriers and facilitators of implementation, and assess participants' satisfaction. General estimating equations (GEE) will be applied to examine the effects of time and group interaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Individuals who give informed consent for this study and are 20 years old or older.
  • •Those who own a smartphone and are willing to join the study's LINE group.
  • •Individuals whose mobile application (APP) can synchronize with the Fitbit Charge 6 wearable device.
  • •Nurses who hold a nursing license and are working in a clinical setting.

排除标准

  • •Individuals unable to provide informed consent for this study and are younger than 20 years old.
  • •Those who do not own a smartphone.
  • •Individuals who do not have a nursing license or are not employed in a clinical setting as a nurse.
  • •Participants who are already involved in other health promotion or exercise training studies.
  • •Nurses who are currently pregnant.

研究组 & 干预措施

Intervention group(wearable devices to initiate behavioral intervention)

Experimental

12 week wearable devices to initiate behavioral intervention including line APP recruited participants and give some behavior change advises, also give a APP-based motivational interviewing 15 minutes per week.

干预措施: wearable devices to initiate behavioral intervention (Behavioral)

comparison group (wearable devices monitor only)

Active Comparator

12 week wearable devices just monitor

干预措施: 12 week wearable devices monitor (Behavioral)

结局指标

主要结局

Physical activity (subjective)

时间窗: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up

Measurement Tool: International Physical Activity Questionnaire short form - Taiwan version

Physical activity (objective)

时间窗: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up

Measurement Tool: Wearing Fitbit Charge 6 HR to collect physical activity and sleep quality related data.

次要结局

  • Body composition(From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up)
  • Sleep quality (objective)(From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up)
  • sleep quality (subjective)(From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up)
  • Stress(From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LO, YIPANG

Head Nurse in emergency department, SongShan Branch

Tri-Service General Hospital

研究点 (1)

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